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The Ethics of Clinical Research on Diseases of the Fetus and Newborn: Balancing Benefit-Risk, Autonomy, and Maternal-Fetal Interests 胎儿与新生儿疾病临床研究的伦理学：平衡利益-风险、自主权及母胎利益 Nelson, Robert M.; Childers, Karla; Ling, Leona E.; Alquier, Lori; Komatsu, Yosuke; Schwartz, Lisa; Stevens, Anne M.; Tjoa, May Lee; Moise Jr, Kenneth J.; Goldkind, Sara F. 分享 收藏
European Bioanalysis Forum recommendation on embracing a context-of-use-driven scientific validation for chromatographic assays in the light of ICH M10 欧洲生物分析论坛关于在ICH M10框架下，采用基于使用场景驱动的科学验证方法对色谱分析法进行验证的建议。 Timmerman, Philip; McDougall, Stuart; Adcock, Neil; Arfvidsson, Cecilia; Barfield, Matthew; Blech, Stefan; Cowan, Kyra J.; Ferrari, Luca; Greco, Alessandro; Golob, Michaela; Goodwin, Lee; Hughes, Richard; Ivanova, Tsvetelina; Lauren, Anna; Nelson, Robert; Neitzel, Sonja; Verhaeghe, Tom; van de Merbel, Nico; Wright, Mike; White, Stephen 分享 收藏
Project GIVE: using a virtual genetics service platform to reduce health inequities and improve access to genomic care in an underserved region of Texas Vuocolo, Blake; Sierra, Roberta; Brooks, Daniel; Holder, Christopher; Urbanski, Lauren; Rodriguez, Keila; Gamez, Jose David; Mulukutla, Surya Narayan; Hernandez, Ana; Allegre, Alberto; Hidalgo, Humberto; Rodriguez, Sarah; Magallan, Sandy; Gibson, Jeremy; Bernini, Juan Carlos; Watson, Melanie; Nelson, Robert; Mellin-Sanchez, Lizbeth; Garcia, Nancy; Berry, Lori; Dai, Hongzheng; Soler-Alfonso, Claudia; Carter, Kent; Lee, Brendan; Lalani, Seema R. 分享 收藏
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Therapeutic Development in Polyarticular Course Juvenile Idiopathic Arthritis: Extrapolation, Dose Selection, and Clinical Trial Design 多关节病程幼年特发性关节炎的治疗进展: 外推，剂量选择和临床试验设计 Schanberg, Laura E.; Mulugeta, Lily (Yeruk); Akinlade, Bolanle; Brunner, Hermine I.; Chen, Jianmeng; Colbert, Robert A.; Delgaizo, Vincent; Gastonguay, Marc R.; Glaser, Rachel; Imundo, Lisa; Lovell, Daniel J.; Leu, Jocelyn H.; Mostafa, Nael M.; Nelson, Robert M.; Nigrovic, Peter A.; Nikolov, Nikolay P.; Rider, Lisa G.; Rothwell, Rebecca; Sahajwalla, Chandrahas; Singh, Renu; Sinha, Vikram; Yancey, Carolyn L.; Yao, Lynne 分享 收藏
Leveraging Prior Knowledge to Support Early Phase Clinical Trial Applications: Regulatory CMC Considerations and Case Studies Hedegaard, Sofie Fogh; Hansen, Rosa Rebecca Erritzoe; Nelson, Robert; Klausen, Niels Kristian; Hjorth, Christian Fogt; Troup, Lori; Eskling, Marie; Storgaard, Morten; Khurshid, Saad; Roberts, Scott W. 分享 收藏
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Paediatric Inflammatory Bowel Disease: A Multi-Stakeholder Perspective to Improve Development of Drugs for Children and Adolescents Croft, Nicholas M.; de Ridder, Lissy; Griffiths, Anne M.; Hyams, Jeffrey S.; Ruemmele, Frank M.; Turner, Dan; Cheng, Katharine; Lutsar, Irja; Greco, Marco; Golebiewska, Zuzanna; Laumond, Floriane; Cavaller-Bellaubi, Maria; Elgreey, Adam; Altepeter, Tara A.; Pallidis, Chrissi; Norga, Koen; Nelson, Robert; Crandall, Wallace; Vassal, Gilles 分享 收藏
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Regulatory strategies for rare diseases under current global regulatory statutes: a discussion with stakeholders Mulberg, Andrew E.; Bucci-Rechtweg, Christina; Giuliano, Joseph; Jacoby, David; Johnson, Franklin K.; Liu, Qing; Marsden, Deborah; McGoohan, Scott; Nelson, Robert; Patel, Nita; Romero, Klaus; Sinha, Vikram; Sitaraman, Sheela; Spaltro, John; Kessler, Vivian 分享 收藏
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Enrollment of Neonates in More Than One Clinical Trial 在一项以上的临床试验中招募新生儿 Davis, Jonathan M.; Baer, Gerri R.; Portman, Ronald; Nelson, Robert; Storari, Linda; Aranda, Jacob V.; Box, Ralph; Zajicek, Anne; Klein, Agnes; Turner, Mark; Baygani, Simin; Thomson, Merran; Allegaert, Karel 分享 收藏
2017 ACC/AAP/AHA Health Policy Statement on Opportunities and Challenges in Pediatric Drug Development Learning From Sildenafil Sable, Craig A.; Ivy, D. Dunbar; Beekman, Robert H., III; Clayton-Jeter, Helene D.; Jenkins, Kathy J.; Mahle, William T.; Morrow, William R.; Murphy, Mary Dianne; Nelson, Robert M.; Rosenthal, Geoffrey L.; Stockbridge, Norman; Wessel, David L. 分享 收藏
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